Rapamycin for Immunosuppression and B Cell Modulation Post Stem Cell Transplant for Acute Lymphoblastic Leukemia (ALL)

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Objectives:

Primary objective: Evaluate toxicity of rapamycin when used for post-bone marrow transplant graft vs. host disease prophylaxis in children with acute lymphoblastic leukemia (ALL).

Investigator initiated; four participating institutions; Phase II pilot study

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Utah
• Collaborator: Children's Hospital of Philadelphia
• Treatments: Everolimus; Sirolimus

Criteria

Inclusion Criteria:

1. Pediatric patients' ages (0 - 21 years) with lymphoid malignancies considered for allogeneic bone marrow transplant from HLA-identical sibling donor, single antigen mismatched related or unrelated donor marrow /peripheral blood stem cell (PBSC) or cord blood available for marrow donation.

First remission:

• if remission not achieved by day28

• high risk cytogenetic features, including t(9;22) or t(4;11) Second or third remission

2. Signed informed consent.

Exclusion Criteria:

1. Organ criteria:

1. Cardiac: ECHO shortening fraction <27%

2. Renal: Creatinine clearance <60 ml/min/1.73 m2

3. Hepatic: Bilirubin >1.5 mg/dl, transaminases <3x normal

4. Infection: active viral, fungal or bacterial infection including HIV.